DEVICE: Henry Schein® Pressure Indicator Paste (D6871721101FG2)

Device Identifier (DI) Information

Henry Schein® Pressure Indicator Paste
1721101FG
In Commercial Distribution
1721101FG
DENTSPLY INTERNATIONAL INC.
D6871721101FG2
HIBCC

100
083235549 *Terms of Use
Henry Schein® Pressure Indicator Paste - 2 oz
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental trial cement A non-sterile substance intended to be used as a guide for selecting a good aesthetic match to the final dental cement to be used in a dental restoration of appliance procedure. It is typically supplied as a water-soluble paste consisting of glycerin, mineral fillers and pigments that does not cure and is intended to be washed off from the restoration and preparation surface prior to final cementation. After application, this device cannot be reused.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EFH PAPER, ARTICULATION
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 33 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 100 Bottles (2 oz each)
Total Volume: 2 Fluid Ounce
CLOSE

Device Record Status

48b5ddb2-d479-45f7-9dfb-9c0a09cf6df8
March 29, 2018
2
September 21, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: D6871721101FG0 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
CLOSE